Four-year review of safe and effective procedural sedation in neonates and young infants.

Objectives: Newborns and small infants are unable to cooperate actively during diagnostic procedures; therefore, sedation is often employee to maintain immobilization and obtain high-quality images. However, these procedures are often indicated in sick, vulnerable, or hemodynamically unstable neonates and young infants, which raises the associated risks of sedation. This study summarizes our 4-year of experience with safe and effective procedural sedation in this vulnerable population. Study design: This retrospective study analyzed data on neonates and young infants who underwent non-painful diagnostic procedures from December 2019 to November 2023. Patients were categorized into the neonate (aged≦ 28 days) and the young infant (29 days ≦ aged ≦ 90 days) groups. Results: Non-pharmacological strategies, including sleeping naturally, swaddling/facilitated tucking, non-nutritive sucking, and skin-to-skin care, can achieve a success rate for sedation about 98.4%. In terms of pharmacological methods, our institution primarily utilizes chloral hydrate for procedural sedation in neonates and young infants undergoing non-painful diagnostic procedures. Midazolam serves as an alternative sedative. Chloral hydrate alone demonstrated a 92.5% success rate on the first attempt, compared to midazolam alone, with an 85.11% success rate. Neonates experienced a higher incidence of adverse events during sedation compared to young infants. Conclusion: This study reviews our 4-year experience with procedural sedation in neonates and young infants. Chloral hydrate demonstrated a high degree of safety and efficacy in this population. However, supervision by skilled medical personnel and extended observation is required. In our institution, the experience with midazolam is limited in this population, and further research is warranted to establish its safety and efficacy. Non-pharmacological strategies can achieve an acceptable rate of sedation success, which can be used based on patient's tolerance.

Predictors of pediatric sedation failure with initial dose of intranasal dexmedetomidine and oral midazolam.

BACKGROUND: To assess the sedative failure rate over different dose combinations of intranasal dexmedetomidine and oral midazolam for procedural sedation. METHODS: This was a retrospective study. Four groups were established according to the initial dose of sedatives. The primary outcome was the sedative failure rate for different doses of the two-drug combination. The risk factors associated with sedation failure were analyzed. RESULTS: A total of 2165 patients were included in the final analysis. Of these, 394 children were classified as sedation failure after the initial dose of a combination of intranasal dexmedetomidine and oral midazolam. Although the initial doses of intranasal dexmedetomidine and oral midazolam administered to patients varied widely, no significant differences were detected in the sedation outcomes among the groups. Multivariate analysis showed that sedation history, a history of sedation failure, and echocardiography were independent risk factors for sedation failure after an initial dose of intranasal dexmedetomidine and oral midazolam. In contrast, patients undergoing lung function and MRI were more likely to be successfully sedated. CONCLUSION: A combination of low-dose intranasal dexmedetomidine and oral midazolam provides adequate sedation efficacy without any increase in side effects, especially for patients undergoing MRI or lung function examination. IMPACT: This is an original article about the risk factors of sedation failure with an initial dose of intranasal dexmedetomidine and oral midazolam for procedure sedation. For patients undergoing echocardiogram, it is better to choose other sedatives, while a combination of intranasal dexmedetomidine and oral midazolam is a good option for patients undergoing MRI or lung function. The selection of sedative drugs should be personalized according to different procedures.

Daytime Variation of Chloral Hydrate-Associated Sedation Outcomes: A Propensity-Matched Cohort Study.

BACKGROUND: Physiological processes influencing a drugs' efficacy change substantially over the course of the day. However, it is unclear whether there is an association between the sedative success rate of chloral hydrate and the time of day. We conducted a retrospective study of 41,831 cases, to determine if there was a difference in sedation success rate with chloral hydrate in children seen in the morning and afternoon. METHODS: Patients who accepted the sedation service were included. Eligible patients were divided into two cohorts of morning and afternoon cases, according to the time of day when the initial dose of chloral hydrate was administered. To ensure that the two groups were comparable, a propensity score matching method was utilized. RESULTS: The success rate with the initial dose of chloral hydrate was higher in patients who received sedation services in the afternoon. In the subgroup analysis, the afternoon cases had a higher sedation success rate compared to the morning cases in male patients; whereas, in female patients, no difference was detected between the morning versus afternoon cases. CONCLUSIONS: These results show that the afternoon cases had a higher sedation success rate than the morning cases, despite the afternoon cases receiving relatively lower initial dose than the morning cases. However, the clinical significance remains to be discussed, and further prospective studies are needed to validate the findings.

Analysis of Risk Factors for Chloral Hydrate Sedative Failure with Initial Dose in Pediatric Patients: a Retrospective Analysis.

BACKGROUND: Although chloral hydrate has been used as a sedative for more than 100 years, dozens of studies have reported that it has inconsistent sedative effects and high sedation failure rates with initial dose. The high failure rates may lead to repeated administration of sedatives, guardians' dissatisfaction, parental anxiety, increasing medical workload as well as leading to an increase of adverse events. Our aim is to identify the risk factors associated with chloral hydrate sedative failure with initial dose in children undergoing noninvasive diagnostic procedures. METHODS: Pediatric patients who underwent chloral hydrate sedation for noninvasive diagnostic procedures at our institution between 1 December 2019 and 1 January 2021 were retrospectively analyzed. Data collected included patients' age, gender, weight, sedation history, sedation failure history, type of procedures, initial dose of choral hydrate, sleep deprivation, sedation failure with initial dose, and sedative duration. The initial dose was classified into three levels: reduced dose (< 40 mg/kg), standard dose (40-60 mg/kg), and high dose (> 60 mg/kg). The patients were divided into three cohorts according to the different initial doses. RESULTS: A total of 15,922 patients were included in the analysis; 1928 (12.1%) were not well-sedated after administering the initial dose of chloral hydrate. The highest sedative failure was observed in the reduced dose group. By multivariate regression, we identified that heavier weight, patients with a history of sedation or a history of sedation failure, and patients who received magnetic resonance imaging (MRI) or more than one procedure simultaneously were associated with an increased odds of sedation failure at the initial dose. However, outpatients, patients undergoing hearing screening, and patients with sleep deprivation were favored regarding chloral hydrate sedative success. CONCLUSION: An alternative drug or drug combination is necessary in patients with heavier weight, those with a sedation history or sedation failure history, and those undergoing an MRI or more than one procedure simultaneously, whereas chloral hydrate is an appropriate sedation option for outpatients, patients undergoing hearing screening, and those with sleep deprivation.

Sleep deprivation did not enhance the success rate of chloral hydrate sedation for non-invasive procedural sedation in pediatric patients.

STUDY OBJECTIVE: In Asian countries, oral chloral hydrate is the most commonly used sedative for non-invasive procedures. Theoretically, mild sleep deprivation could be considered as one of assisted techniques. However, there is no consensus on sleep deprivation facilitating the sedation during non-painful procedures in children. The aim of our study is to analyze the clinical data of children undergoing non-invasive procedural sedation retrospectively and to evaluate the association between mild sleep deprivation and sedative effects in non-invasive procedures. MEASUREMENTS: Consecutive patients undergoing chloral hydrate sedation for non-invasive procedures between December 1, 2019 to June 30, 2020 were included in this study. The propensity score analysis with 1: 1 ratio was used to match the baseline variables between patients with sleep deprivation and non-sleep deprivation. The primary outcome was the failure rate of sedation with the initial dose. The secondary outcomes included the failure rate of sedation after supplementation of chloral hydrate, the incidence of major and minor adverse events, initial and supplemental dose of chloral hydrate, and the length of sedation time. MAIN RESULTS: Of the 7789 patients undergoing chloral hydrate sedation, 6352 were treated with sleep deprivation and 1437 with non-sleep deprivation. After propensity score matching, 1437 pairs were produced. The failure rate of sedation with initial chlorate hydrate was not significantly different in two groups (8.6% [123/1437] vs. 10.6% [152/1437], p = 0.08), nor were the failure rates with supplemental chlorate hydrate (0.8% [12/1437] vs. 0.9% [13/1437], p = 1) and the length of sedation time (58 [45, 75] vs. 58 [45, 75] min; p = 0.93). CONCLUSIONS: The current results do not support sleep deprivation have a beneficial effect in reducing the pediatric chloral hydrate sedation failure rate. The routine use of sleep deprivation for pediatric sedation is unnecessary.